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Epigenomics' Q3 Revenues Fall 29 Percent; PMA Submission Targeted for Epi proColon 2.0

NEW YORK (GenomeWeb News) – German cancer molecular diagnostics firm Epigenomics today reported revenues in the third quarter fell 29 percent year over year while its net loss increased by 60 percent.

For the three months ended Sept. 30, revenues totaled €257,000 ($349,000), compared to €363,000 ($493,000) a year ago, while its net loss rose to €4.8 million from €3 million.

This past summer the company announced a restructuring effort with one of its goals to relocate its US operation to the East Coast from Seattle. Epigenomics today reiterated that goal, saying it expects the move to happen in 2012.

It also repeated its plans to cut the number of employees to 45 from 84, though it extended the target date for those actions to the end of Q1 2012 from an earlier stated timeline of the end of 2011.

R&D efforts, Epigenomics said, are focused on existing and near-term product opportunities, and longer-term projects have been put on hold. Meanwhile, all early-stage and technology research efforts have been discontinued, and direct marketing and sales efforts to the European self-payer market have been scaled down.

The restructuring is expected to impact fourth-quarter results, though to a smaller degree, and the company anticipates annual savings on a comparable cost structure of about €3.5 million to €4 million.

During the third quarter, the firm said, it readjusted its commercial strategy in Europe to target payers and large institutional customers "deeply entrenched in the healthcare system, including distributors of selected European countries."

Late last month Epigenomics launched its Epi proColon 2.0 colorectal cancer test in Europe as a CE-marked product. Today, it said that the introduction is "a means to re-enter the market with a significantly stronger value proposition to clinicians and patients."

The second generation of the Epi proColon test was based on a case-controlled clinical validation study in which the test was able to achieve 95 percent sensitivity and 85 percent specificity. Based on the study, the firm has begun a second validation study in preparation of filing a premarket approval submission to the US Food and Drug Administration.

The US study, started in September, is being conducted at three sites and involves blood samples from a study cohort of about 8,000 subjects. It is expected to be completed before the end of the year.

"The main focus of the organization has remained on the development of the second generation blood-based Epi proColon test with the goal to file a PMA with the FDA by the end of the year, and the recent launch in Europe as a CE-marked IVD product," the company said in a statement. It added that it is working with partners such as Abbott Molecular, Qiagen, and Sysmex as they commercial their own septin9-based tests for colorectal cancer.

For full-year 2011, it said that revenues are anticipated to be "in the same range" as revenues in 2010, which were €1.8 million.

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